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Special Feature on Sievers Products for Pharmaceutical Water Management

Contamination management strategies for pharmaceutical water (CCS), real-time testing of pharmaceutical water, cleaning validation, and more… Please feel free to consult us with any concerns!

【 Sievers M9 】This TOC analyzer, with its unique gas-permeable membrane conductivity measurement method and wide measurement range, can accommodate various applications. - No carrier gas required - Stability in ultra-low concentration ranges - 12 months of calibration stability - Compliance with data integrity requirements based on 21 CFR Part 11 (optional) 【 Sievers Soleil 】This rapid analysis device detects fewer than 10 viable bacteria in 100 mL with ultra-high purity within 45 minutes. - Assists in rapid decision-making: Quality control of pharmaceutical water / Cleaning validation 【 Sievers Eclipse 】This endotoxin meter is designed for easy endotoxin measurement by anyone. - Semi-automated measurement with dedicated microplates and microfluidic technology - Less than 30 pipetting operations, significantly reducing preparation time and effort (21 samples) - Reduced usage of lysate reagents 【 Sievers M500 】This third-generation online TOC analyzer has evolved from reagent-free gas-permeable membrane conductivity measurement technology. - Real-time measurement at 3-minute intervals - Compliance with data integrity based on 21 CFR Part 11

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basic information

【Sievers Soleil - BioBurden Rapid Analysis Device】 Measurement Range: Less than 10 biotics/100 mL to less than 10,000 biotics/100 mL Sample Volume: 20 mL to 100 mL Measurement Time: Less than 45 minutes 【Sievers M9 Series - TOC Analyzer】 Measurement Method: Wet UV oxidation + Gas permeable membrane conductivity measurement method Measurement Range: (Normal) 0.03 ppb to 50 ppm, (Turbo Mode) 0.2 to 10 ppm Measurement Interval: (Normal) 2 minutes, (Turbo Mode) 4 seconds 【Sievers M500 Series - TOC Analyzer】 Measurement Method: Wet UV oxidation + Gas permeable membrane conductivity measurement method Measurement Range: 0.03 to 2,500 ppb TOC 【Sievers Eclipse - Endotoxin Analyzer】 Measurement Principle: Kinetic colorimetric method/Turbidity method Detection Method: Absorbance Measurement Range: 0.005 to 50 EU/mL

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Applications/Examples of results

【Sievers M9 Series, M500 Series - TOC Analyzer】 - Real-time testing (RTT) of pharmaceutical water - Offline testing of pharmaceutical water - Cleaning validation 【Sievers Eclipse - Endotoxin Analyzer】 - Endotoxin measurement for pharmaceuticals and injectable water 【Sievers Soleil - Bio-burden Rapid Analysis Device】 - Quality control of pharmaceutical water - Process samples - Product shipment testing

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Model number overview
Sievers M9 TOC measurement (lab type / portable type / online type)
Sievers M500 TOC Measurement (Online Type)
Sievers Soleil BioBurden Rapid Analysis Device
Sievers Eclipse Endotoxin meter

catalog(10)

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BioBurden Rapid Analysis Device Sievers Soleil

PRODUCT

TOC Analyzer for Pharmaceuticals Sievers M9

PRODUCT

Online TOC Analyzer Sievers M500

PRODUCT

Sievers Endotoxin Measurement Eclipse

PRODUCT

Best practices for risk assessment applicable to RTT.

APPLICATION_NOTE

Best Practices for Out of Specification (OOS) Investigation Results

APPLICATION_NOTE

Real-time TOC testing of PAT and pharmaceutical water

TECHNICAL

Real-time test validation support package for pharmaceutical water.

APPLICATION_NOTE

Sievers TOC Sensor CheckPoint Pharma

PRODUCT

Maintaining data integrity during the transfer to RTT.

APPLICATION_NOTE

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Distributors

Since our establishment in 1967, we have been dedicated to the development and dissemination of water quality measurement devices that anyone can use quickly, easily, and with high precision. In today's world, where the effective use of water, a limited resource, is required alongside environmental conservation, we aim to be a total solution provider that responds to all water environments by utilizing our water quality measurement devices, technology, and services. Furthermore, leveraging the latest technology and years of know-how, we are committed to delivering user-friendly and reliable water quality measurement devices more affordably, quickly, and widely.